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GLP Data Management and Integrity Audit Checklist

A comprehensive checklist for auditing data management practices and ensuring data integrity in GLP-regulated pharmaceutical laboratories, covering all aspects of data lifecycle from generation to archiving.

GLP Data Management and Integrity Audit Checklist

by: audit-now
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About This Checklist

Maintaining data integrity is paramount in Good Laboratory Practice (GLP) compliance for the pharmaceutical industry. This GLP Data Management and Integrity Audit Checklist is an essential tool for quality assurance professionals, data managers, and IT specialists to evaluate and ensure the robustness of data handling processes in GLP-regulated environments. By implementing this checklist, pharmaceutical organizations can strengthen their data governance, minimize the risk of data integrity breaches, and demonstrate compliance with regulatory expectations for data reliability and traceability.

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Industry

Healthcare

Standard

GLP - Good Laboratory Practice

Workspaces

Pharmaceutical Research and Development Laboratory

Occupations

Quality Assurance Specialist
Data Integrity Manager
IT Compliance Officer
Laboratory Information Management System (LIMS) Administrator
GLP Auditor
1
Is the data integrity maintained in compliance with ALCOA+ principles?

Select the compliance status.

To ensure that data integrity is upheld according to established principles.
2
Describe the process for reviewing audit trails of electronic data systems.

Provide a detailed description of the audit trail review process.

To evaluate the effectiveness of the audit trail system in maintaining data integrity.
3
On a scale of 1-5, how effective is the data lifecycle management process?

Rate the effectiveness from 1 (Very Poor) to 5 (Excellent).

To assess the effectiveness of data lifecycle management in the laboratory.
Min: 1
Target: 3
Max: 5
4
What is the current status of data security measures in place?

Select the current data security status.

To determine the effectiveness of data security measures implemented.
5
Is the laboratory compliant with current GLP regulations?

Select the compliance status.

To evaluate adherence to Good Laboratory Practice standards.
6
Outline the corrective action plan for any identified non-compliance.

Provide a detailed corrective action plan.

To ensure that there is a clear plan to address compliance issues.
7
Rate the training compliance of staff on GLP procedures from 1-5.

Rate the training compliance from 1 (Very Poor) to 5 (Excellent).

To assess the effectiveness of training programs on GLP compliance.
Min: 1
Target: 4
Max: 5
8
What was the date of the last compliance audit?

Enter the date of the last compliance audit.

To track the frequency and recency of compliance audits.
9
Is there an established data governance framework in the laboratory?

Select the status of the data governance framework.

To determine whether proper data governance practices are in place.
10
Describe the data quality assurance process implemented in the laboratory.

Provide a detailed description of the data quality assurance process.

To evaluate the measures taken to ensure data quality.
11
On a scale of 1-5, how effective are the data access controls in place?

Rate the effectiveness from 1 (Very Poor) to 5 (Excellent).

To assess the effectiveness of data access controls in protecting sensitive data.
Min: 1
Target: 4
Max: 5
12
How prepared is the laboratory for data incident response?

Select the preparedness level for incident response.

To evaluate the readiness of the laboratory to respond to data-related incidents.
13
Is the electronic data system compliant with regulatory standards?

Select the compliance status of the electronic data system.

To ensure that the electronic data system meets regulatory requirements.
14
Outline the procedures for data backup within the electronic data systems.

Provide a detailed outline of the data backup procedures.

To evaluate the effectiveness of data backup measures in place.
15
How many times has the electronic data system experienced downtime in the last year?

Enter the number of downtimes experienced.

To assess the reliability and availability of the electronic data system.
Min: 0
Target: 3
Max: 100
16
When was the last validation of the electronic data system conducted?

Enter the date of the last system validation.

To track compliance with validation requirements for electronic systems.
17
Is sensitive data encrypted in accordance with industry standards?

Select the encryption status of sensitive data.

To ensure that sensitive data is protected through encryption.
18
Describe the access control measures in place for sensitive data.

Provide a detailed description of the access control measures.

To evaluate the effectiveness of access controls protecting data.
19
What is the average response time (in hours) to data security incidents?

Enter the average response time in hours.

To assess the responsiveness of the incident response protocols.
Min: 0
Target: 2
Max: 48
20
When was the last data security audit performed?

Enter the date of the last data security audit.

To track the frequency of data security audits conducted.

FAQs

The checklist covers areas such as data acquisition, processing, storage, archiving, security measures, audit trails, electronic signatures, and data backup and recovery processes.

Data integrity audits should be conducted at least annually, with more frequent checks recommended for critical systems or after significant changes to data management processes or technologies.

The audit should involve a cross-functional team including quality assurance personnel, IT specialists, data managers, and representatives from relevant laboratory departments to ensure a comprehensive review.

By regularly using this checklist, organizations can proactively identify and address data integrity issues, maintain comprehensive documentation of data management practices, and demonstrate a commitment to GLP principles, thus enhancing preparedness for regulatory inspections.

Yes, while the checklist has a strong focus on electronic data systems, it also includes elements relevant to paper-based records and hybrid systems to ensure comprehensive coverage of all data types in GLP environments.

Benefits of GLP Data Management and Integrity Audit Checklist

Ensures comprehensive assessment of data integrity practices

Helps identify and mitigate risks in data management processes

Facilitates compliance with GLP data integrity requirements

Supports the development of robust data governance strategies

Enhances the overall quality and reliability of laboratory data